Positive change in the Bloodstream infections and Cataract connectors: the first communication to the

Sent date: 11. August 2010

Public:Health professionals

Medical Specialty:Infection Control

A summary of the issue and scope:

A number of peer review, clinical trials, a report on the putting into service and use of positive displacement, as well as health-care establishments needleless connectors to the reduction of infection after changing to another type of bloodstream infections needleless connector.However, the amount of the bloodstream infection risk compared to other needleless devices, these connectors, or whether the risk of some or all of the information relating to the positive displacement is probably the connectors were incomplete. FDA is ordering product safety to better understand the use of bloodstream infections, the risk of positive displacement connectors needleless.

Device:

Positive displacement needleless connector is part of the system, with regard to the use of intravascular needleless. these devices can also be referred to as the "activated luer valves," "connectors," or "run" and may refer to the "positive pressure" or "positive displacement", their descriptions.

Healthcare Professionals recommendations:

In 2008, the two professional associations adopted guidelines for the small hospital acquired infections (http://www.journals.uchicago.edu/toc/iche/2008/29/s1). For the purpose of these guidelines, in so far as it is not, as a matter of routine, "do not use positive pressure connectors mechanical valves before needleless risks, benefits and proper management of a foods natural appetite suppressors
thorough assessment of the training."FDA's original assessment supports this recommendation.

Postmarket Surveillance Studies

FDA requires companies that produce positive displacement postmarket surveillance tests needleless connectors. studies clarify these devices in order to limit the risk of infection and the risks and benefits. manufacturers shall provide for the collection of information to patients who have received the patients who have received compared with other types of connectors needleless devices bloodstream infections: for more information, see the FDA Letter infection control professionals.

Reporting problems with FDA

Prompt notification of adverse events to help the FDA identify and better understand the risks associated with medical. If you suspect problems with the use of positive displacement needleless connectors, we recommend a voluntary report, FDA MedWatch safety information and events through the reporting program to a file. medical devices by the FDA for reporting in device action is subject to the staff in their facilities reporting procedures.

Health care providers are invited to inform the port facility also infected control staff, where they have doubts concerning the positive displacement connector into the bloodstream infection needleless.

Contact information:

If you have any questions about communication, contact small manufacturers Division, International and Consumer Assistance (DSMICA) dsmica@fda.hhs.gov or 800-638-2041.

For more information about:

This document reflects the FDA in accordance with the information available to the public are informed of the ongoing safety reviews of medical devices in order to reinforce our commitment to the nature of the current analysis., and this situation will not be liable for any public health effects are not yet clear.